Z-0232-2018Class II

FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The...

Name: Z-0232-2018 FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2017-06-15
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2017-06-15 / Terminated / root cause: design

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate... on 2017-06-15. FDA classified it as Class II and gives the reason as "A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0232-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-15
Posted: 2017-12-10
Terminated: 2018-05-09
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.
Product code: KPR System, X-Ray, Stationary
Reason for recall: A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Root cause tag: design
FDA root cause: Device Design
Action: FUJIFILM Medical Systems U.S. A. Inc. (FMSU) sent "Urgent: Medial Device Correction" recall notification letter dated June 21, 2017 to all Customers. Customers were notified of the recall, potential issue, potential hazard, description of the issue, the actions planned to correct the issue, the actions to be taken by the customer and contact information. A Customer Feedback Form was provided accompanying the letter. FMSU service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures. As FMSUs planned field correction at the affected sites, FMSU will install the additional protective parts preventing the X-ray tube assembly from coming into contact with the patient or operator should separation of the tube mounting flange from the tube holding shaft occur. For further questions, please call (203) 324-2000.
Quantity in commerce: 3
Distribution: US Distribution.
Product codes and lots: UDI: (01)04540217052226(21)MP95A9F6B001; (01)04540217052226(21)MP95A9F6A001; (01)04540217052226(21)MP95A8F5A001. Serial Numbers: FDR Visionary Suite System S/N MP95A9F6B001 MP95A9F6A001 MP95A8F5A001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0232-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0232-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-10

Product code KPR

K152294Class IIFDR Visionary SuiteShimadzu Corporation / cleared 2016-07-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)